NCT05300776

Brief Summary

The purpose of this study is to determine the value of M-ROSE（microbiological rapid on-site evaluation）in severe hospital-acquired pneumonia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

March 8, 2022

Last Update Submit

April 19, 2022

Conditions

Pneumonia

Keywords

M-ROSEmNGSsevere hospital-acquired pneumoniatreatment

Outcome Measures

Primary Outcomes (1)

  • mortality

    Alive or Dead.

    During the intervention.

Secondary Outcomes (6)

  • Blood leukocyte ratio tread

    During the intervention.

  • 28 day outcome

    28 days after admission

  • Blood neutriphil ratio tread

    During the intervention.

  • Blood interleukin 6 tread

    During the intervention.

  • Blood C-reactive protein

    During the intervention.

  • +1 more secondary outcomes

Study Arms (2)

M-ROSE combined with mNGS group

EXPERIMENTAL

The bronchoalveolar lavage fluid (BALF) of patients undergoes M-ROSE analysis and decide whether the samples are qualified, whether they indicate bacterial infection and identify pathogens, and the qualified samples are sent for mNGS analysis. The individualized anti-infection treatment is comprehensively guided according to the results of M-ROSE, mNGS and clinical examinations.

Diagnostic Test: M-ROSE analysis

mNGS group

NO INTERVENTION

BALF samples were directly sent for mNGS analysis, and anti-infective treatment was guided according to clinical examinations.

Interventions

M-ROSE analysisDIAGNOSTIC_TEST

The M-ROSE analysis process consists of 3 procudures. 1. Specimen quality assessment. The BALF undergoes the process of smear, diff-quik stain, gram stain and are analyzed by experts to report the cytoloy and pathogen patterns to determine whether the sample is qualified according to the cell proportions. The qualified BALF samples are: squamous epithelial cell proportion\<1%, columnar epithelial cell proportion \<5% . 2. Distinguish infection and colonization. According to the cytoloy pattern, the proportion of neutrophils \> 50% often strongly suggests pulmonary bacterial infection; Neutrophil phagocytosis proportion\> 5% indicates infection, and phagocytosis of bacteria is the pathogen. Besides, fungal and hyphae can be found under the microscope. 3. Preliminary identification of infectious pathogens. Identify the infected bacteria and fungi, and the results are gram-positive cocci, gram-positive bacilli, gram-negative cocci, gram-negative bacilli, yeasts and molds.

M-ROSE combined with mNGS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of severe hospital-acquired pneumonia
  • Must have undergone bronchoalveolar lavage

You may not qualify if:

  • BALF samples were not sent for mNGS examination
  • Age \< 18 years old
  • The hospitalization days ≤ 3
  • The clinical data are incomplete
  • Mechanical ventilation time \> 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yi Tao

Beijing, Beijing Municipality, 100083, China

RECRUITING

Related Publications (1)

  • Wang X, Wang K, Xie F, Han Z, Liu Y, Pan L, Zhu G, Cao Z, Yan P, Xiao L, Duan Z, Hu Y, Xiao K, Chen X, Fu H, Shi Y, Song Y, Han X, Xie W, Xie L. Protocol of a multicenter, single-blind, randomized, parallel controlled trial evaluating the effect of microbiological rapid on-site evaluation (M-ROSE) guiding anti-infection treatment in patients with severe hospital-acquired pneumonia. Trials. 2023 Aug 23;24(1):552. doi: 10.1186/s13063-023-07570-z.

    PMID: 37612723DERIVED

MeSH Terms

Conditions

PneumoniaHealthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lixin Xie, Ph.D

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Tao, Ph.D

CONTACT

+8617797708263taoyimmu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 29, 2022

Study Start

May 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)